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AIDgastro: Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

Sponsor
Imperial College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05795309
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.

Condition or Disease Intervention/Treatment Phase
  • Device: Hybrid Automated Insulin Delivery
 N/A

Detailed Description

Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Staggered randomised control trialStaggered randomised control trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hybrid Automated Insulin Delivery

The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system

Device: Hybrid Automated Insulin Delivery
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Other Names:
  • Medtronic 780G

    		•
    No Intervention: Standard care

    The control is Standard Care with real-time CGM

    Outcome Measures

    Primary Outcome Measures

    1. % time spent in glucose target (3.9-10mmol/L) [4 - 8 weeks]

      The change in % time in glucose target between baseline and intervention/control

    Secondary Outcome Measures

    1. % time spent in hypoglycaemia (<3.0mmol/L) [4 - 8 weeks]

      The change in % time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control

    2. % time spent in hypoglycaemia (<3.9mmol/L) [4 - 8 weeks]

      The change in % time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control

    3. % time spent in hyperglycaemia (>10mmol/L) [4 - 8 weeks]

      The change in % time in hyperglycaemia (>10mmol/L) between baseline and intervention/control

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged 18 years of age or older

    • Type 1 diabetes confirmed on the basis of clinical features

    • Type 1 diabetes for greater than 1 year

    • On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months

    • HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)

    • Gastroparesis Cardinal Symptom Index (GCSI) ≥ 18 or evidence of delayed gastric emptying on nuclear medicine gastric emptying study

    Exclusion Criteria:

    • Enrolled in other clinical trials

    • Estimated glomerular filtration rate of ≤30ml/min

    • Pregnant or planning pregnancy

    • Have active malignancy or under investigation for malignancy

    • Severe visual impairment

    • Reduced manual dexterity

    • Use of any automated insulin delivery system

    • Unable to participate due to other factors, as assessed by the Chief Investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Imperial College London and Imperial College Healthcare NHS Trust London United Kingdom W12 0HS

    Sponsors and Collaborators

    • Imperial College London

    Investigators

    • Principal Investigator: Nick Oliver, Imperial College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT05795309
    Other Study ID Numbers:
    • 22HH8008
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 3, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Gastroparesis
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Insulin

    Study Results

    No Results Posted as of Apr 3, 2023